Medical Study Volunteer

You may be asked to volunteer for a research study.

This booklet will help you understand your rights as a research volunteer and help you to decide if you should take part. It will also help you understand some of the basic requirements for good research. We urge you to review this information and discuss it with other people you trust. Here are some things you need to know:

• If anyone asks you to take part in a research study, you have the right to say “no”
• Your decision will not affect your relationship with the organization conducting the research
• You need to weigh both the risks of the study and the benefits
• It may be helpful to talk with family, friends or other people you trust
• If you decide to take part in a research study, you can change your mind and stop or leave the study at any time without retaliation

Other studies find out what education practices work best while more might use a survey or an interview to understand needs, problems or feelings people have about an important topic. Studies are also conducted to determine the best way to treat or prevent an illness.

• Help scientists find out more about how the human body and mind work
• Help other people or honor a loved one
• Help find a cure for an illness

If you decide to take part in a research study, you do so as a volunteer. That means you get to decide whether you will take part. If you choose to participate, you have many important rights.

No one can predict the outcome of a research study or how it might affect you. The study may not help you personally, but your taking part could result in information that helps others in the future.

Some benefits to you might include:

• Access to new and advanced therapies and treatment strategies before they’re available to the public
• Improvements in quality of life
• Monetary incentives

The IRB serves to protect your rights and welfare before and during the research study. For example, the IRB makes sure that any risks in the research study are as small as possible. The IRB does not make a decision for you. The IRB decides, when approving research studies, that it is reasonable to ask people whether they want to be involved in it. The IRB also reviews each study while it’s going on to ensure volunteers are protected.

The research staff will discuss known possible risks with you so you can decide if you want to volunteer. If you do volunteer, the research staff will tell you about any new risks that they learn about during the study for as long as you take part in it.

The following is a list of sample questions. Not every question will apply to every study. Remember, if you do not understand the answer to one of your questions, ask the question again and ask the person to explain the answer in a way you can understand it. If you forget the answers to the questions during the study, ask them again.

Some questions to ask include:

• Who is doing this study and what question might it answer?
• Will this research help in understanding my condition? If so, how?
• What tests or procedures will be performed?
• Will I have to make extra trips?
• What could happen to me, good or bad, if I take part in the study?
• How long will the study last?
• What will happen to any specimens I provide?
• Who has reviewed and approved this study?
• Could I get worse during the study? What will happen if I do?
• What other options do I have if I decide not to take part in the study?
• Will I be charged or paid anything to be in this study?
• If I decide to take part in this study, how will it affect my daily life?
• What will happen to me at the end of the study?
• Will I be told the results of the study?
• Who will find out that I am taking part in this study?
• How do I stop taking part in the study if I change my mind?
• Who do I contact for questions and information about the study?

More Information

Informed consent begins when the research staff explains the facts to you about the research study.

The research staff will assist you with the “informed consent document” that goes over these facts so you can decide whether you want to take part in the study. These facts include details about the study, procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer.

If English isn't your native tongue, ask for an interpreter to be present when you are discussing the study with the research staff. The written and verbal informed consent information will be given to you in a language that you know. You can take the information home with you and discuss it with your family, friends, a health care provider or others before you decide whether to take part in the study.

If you decide to take part in the study, you will be asked to sign the informed consent form. However, the informed consent process is more than just signing a piece of paper. It is a process that goes on throughout the study. During the study, you may be told of new findings, benefits or risks. At that time, you can decide whether to continue participating in the study. You may change your mind and leave the study before it starts or leave at any time during the study or the follow-up period.

The groups of individuals who might look at your records are the research staff, the Institutional Review Board (IRB), the company or group funding the study and various government oversight agencies. It’s important for these groups to be able to review your records so they can ensure the study is conducted with acceptable research practices.